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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat)
Healthcraft Products Inc.
INV-WS26-ASH-BLK
In Commercial Distribution

  • 00689281031738 ()
03173

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat)
Healthcraft Products Inc.
INV-WS18-ASH-BLK
In Commercial Distribution

  • 00689281031721 ()
03172

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat)
Healthcraft Products Inc.
INV-WS26-WNT-BLK
In Commercial Distribution

  • 00689281031714 ()
03171

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat)
Healthcraft Products Inc.
INV-WS18-WNT-BLK
In Commercial Distribution

  • 00689281031707 ()
03170

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Healthcraft Products Inc.
INV-WS26-ASH-PCG
In Commercial Distribution

  • 00689281031622 ()
03162

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Healthcraft Products Inc.
INV-WS18-WNT-ORB
In Commercial Distribution

  • 00689281031332 ()
03133

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Healthcraft Products Inc.
INV-WS18-WNT-CRP
In Commercial Distribution

  • 00689281031318 ()
03131

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Healthcraft Products Inc.
INV-WS26-ASH-CRP
In Commercial Distribution

  • 00689281031288 ()


  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Healthcraft Products Inc.
INV-WS26-ASH-BN
In Commercial Distribution

  • 00689281031271 ()
03127

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Healthcraft Products Inc.
INV-WS18-ASH-ORB
In Commercial Distribution

  • 00689281031257 ()
031257

  • Shower seat, non-powered
The Serena-Seat is a high quality, commercial grade, fold down shower seat. The Serena-Seat is intended to provide shower seating support for people with reduced mobility. The Serena-Seat is intended to bear weight ONLY when the seat is in the down position; the seat is not intended to bear weight in any other position. The Serena-Seat is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The Serena-Seat is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight (i.e. do not stand on the seat).
Healthcraft Products Inc.
INV-WS18-ASH-CRP
In Commercial Distribution

  • 00689281031240 ()
03124

  • Shower seat, non-powered
Accell TBM, 7 cm diameter - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty.
ISOTIS ORTHOBIOLOGICS, INC.
02-4000-760
In Commercial Distribution

  • M3860240007601 ()
  • 10889981055660 ()

  • 7cm Round
02-4000-760

  • Bone matrix implant, human-derived
Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.
Acera Surgical Inc
C1-5X7
In Commercial Distribution

  • 00854258006051 ()

  • Length: 17.5 Centimeter
  • Width: 12.5 Centimeter
  • Length: 7 Inch
  • Width: 5 Inch


  • Dura mater graft, synthetic
Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.
Acera Surgical Inc
C1-4X5
In Commercial Distribution

  • 00854258006044 ()

  • Length: 12.5 Centimeter
  • Width: 10 Centimeter
  • Length: 5 Inch
  • Width: 4 Inch


  • Dura mater graft, synthetic
Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.
Acera Surgical Inc
C1-3X3
In Commercial Distribution

  • 00854258006037 ()

  • Width: 7.5 Centimeter
  • Length: 7.5 Centimeter
  • Width: 3 Inch
  • Length: 3 Inch


  • Dura mater graft, synthetic
Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.
Acera Surgical Inc
C1-2X2
In Commercial Distribution

  • 00854258006020 ()

  • Width: 5 Centimeter
  • Length: 5 Centimeter
  • Width: 2 Inch
  • Length: 2 Inch


  • Dura mater graft, synthetic
Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.
Acera Surgical Inc
C1-1X3
In Commercial Distribution

  • 00854258006013 ()

  • Length: 7.5 Centimeter
  • Width: 2.5 Centimeter
  • Length: 3 Inch
  • Width: 1 Inch


  • Dura mater graft, synthetic
Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable,nonfriable, porous polymer matrix.
Acera Surgical Inc
C1-1X1
In Commercial Distribution

  • 00854258006006 ()

  • Width: 2.5 Centimeter
  • Length: 2.5 Centimeter
  • Width: 1 Inch
  • Length: 1 Inch


  • Dura mater graft, synthetic
The VT300 is a wall-mounted radiographic cassette holder. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.
Del Medical, Inc.
VT300 (5150)
In Commercial Distribution

  • 00858340006363 ()


  • X-ray film cassette holder
The VT300 is a wall-mounted radiographic cassette holder. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.
Del Medical, Inc.
VT300 (5157)
In Commercial Distribution

  • 00858340006356 ()


  • X-ray film cassette holder
The VS300 is a wall-mounted radiographic cassette holder. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.
Del Medical, Inc.
VS300
In Commercial Distribution

  • 00858340006349 ()


  • X-ray film cassette holder
The VS100 is a wall-mounted radiographic cassette holder. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.
Del Medical, Inc.
VS100
In Commercial Distribution

  • 00858340006332 ()


  • X-ray film cassette holder
The VT300T is a wall-mounted radiographic cassette holder. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.
Del Medical, Inc.
VT300T
In Commercial Distribution

  • 00858340006141 ()


  • X-ray film cassette holder
MD-Temp is a temporary resin for formation of temporary fillings, and other temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. It is a hydraulic temporary restorative.
Meta Biomed Co., Ltd.
9213
In Commercial Distribution

  • 08806387892137 ()


  • Temporary dental crown/bridge
MD-Temp is a temporary resin for formation of temporary fillings, and other temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. It is a hydraulic temporary restorative.
Meta Biomed Co., Ltd.
9212
In Commercial Distribution

  • 08806387892120 ()


  • Temporary dental crown/bridge
Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided.
Sonic Incytes Medical Corp.
LI-1005
In Commercial Distribution

  • B995LI10050 ()


  • Hepatic ultrasound elastography system
GammaZyme-F is used in two-stage (pretreatment of red blood cells) enzyme test systems for blood group antibody detection. GammaZyme-F is a stabilized solution of ficin, and this product is in a single vial configuration.
IMMUCOR, INC.
0007056
In Commercial Distribution

  • 10888234000709 ()
0007056

  • Ficin immunohaematology reagent IVD
CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F20100ER
In Commercial Distribution

  • 04540778159976 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 100 mm
  • Balloon Diameter; 2.0 mm
BD-F20100ER

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F60080ER
In Commercial Distribution

  • 04540778159952 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 4.1 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 6.0 mm
BD-F60080ER

  • Peripheral angioplasty balloon catheter, basic
CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
KANEKA CORPORATION
BD-F50080ER
In Commercial Distribution

  • 04540778159938 ()

  • Maximum Guidewire Diameter; 0.018 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.4 Fr
  • Distal Shaft Diameter; 4.0 Fr
  • Catheter Working Length; 2000 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 5.0 mm
BD-F50080ER

  • Peripheral angioplasty balloon catheter, basic
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